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Hip Spacer Molds with stainless-steel reinforcement stems, centralizers and Hip Head Inserts are indicated for use to mold a temporary hemi-hip spacer for skeletally mature patients undergoing a two-stage revision procedure due to a septic process. The temporary hemi-hip spacer is molded using Cemex Genta LV, and inserted into femoral medullary canal and acetabular cavity following removal of the existing femoral and acetabular implants and debridement. The device is intended for use in conjunction with systemic antibiotic therapy (standard treatment approach to an infection). The temporary hemi-hip spacer made from Hip Spacer Molds is not intended for use more than 180 days, at which time it must be explanted, and permanent devices implanted, or another appropriate treatment performed (e.g., resection arthroplasty, fusion, etc.). Due to the inherent mechanical limitations of the temporary hemi-hip spacer material (Cemex Genta LV) the temporary hemi-hip spacers is only indicated for patients who will consistently use traditional mobility assist devices (e.g., crutches, walkers) throughout the implant period.

Femoral Knee Spacer Molds and Tibial Knee Spacer Molds are indicated for use to mold a temporary total knee replacement (TKR) for skeletally mature patients undergoing a two-stage revision procedure due to a septic process. The temporary prosthesis is molded using Cemex Genta LV and inserted into the joint space following removal of the existing total knee replacement implants and debridement. The device is intended for use in conjunction with systemic antimicrobial antibiotic therapy (standard treatment approach to an infection). The temporary total knee spacer made from the Femoral Knee Spacer Molds and Tibial Knee Spacer Molds is not intended for use more than 180 days, at which time it must be explanted, and permanent devices implanted, or another appropriate treatment performed (e.g., resection arthroplasty fusion, etc.). Due to the inherent mechanical limitations of the temporary total knee spacer material (Cemex Genta LV), the temporary total knee spacer is only indicated for patients who will consistently use traditional mobility devices (e.q., crutches, walkers) throughout the implant period.

Shoulder Spacer Molds with stainless-steel reinforcement stems, centralizers and Shoulder Head Inserts are indicated for use to mold a temporary hemi-shoulder spacer for skeletally mature patients undergoing a two-stage revision procedure due to a septic process. The temporary hemi-shoulder spacer is molded using Cemex Genta LV, and inserted into femoral medullary canal and acetabular cavity following removal of the existing femoral and acetabular implants and debridement. The device is intended for use in conjunction with systemic antibiotic therapy (standard treatment approach to an infection). The temporary hemi-shoulder spacer made from Shoulder Spacer Molds is not intended for use more than 180 days, at which time it must be explanted, and permanent devices implanted, or another appropriate treatment performed (e.g., resection arthroplasty, fusion, etc.). Due to the inherent mechanical limitations of hemi-shoulder prothesis material (Cemex Genta LV) the temporary hemi-shoulder prothesis is only indicated for patients who will consistently follow activity limitations throughout the implant period.

The Hip Spacer Molds are sterile, single use molds used for forming of interim prothesis from bone cement. These interim prothesis are intended as temporary hemi-hip spacers in a two-stage septic hip joint endoprosthesis. The Hip Spacer Molds are available as modular system, which is combinable to obtain different sized spacers.

The Femoral and Tibial Knee Spacer Molds are sterile, single use molds used for forming of interim prothesis from bone cement. These interim prothesis are intended as temporary knee spacers in a two-stage septic knee joint endoprosthesis. The Knee Spacer Molds are available as modular system, which is combinable to obtain different sized spacers.

The Shoulder Spacer Molds are sterile, sinqle use molds used for forming of interim prothesis from bone cement. These interim prothesis are intended as temporary hemishoulder spacers in a two-stage septic glenohumeral joint endoprosthesis. The Shoulder Spacer Molds are available as modular system, which is combinable to obtain different sized spacers.

This FDA 510(k) clearance letter pertains to medical device molds (Hip, Knee, Shoulder Spacer Molds) used to create temporary orthopedic spacers. The submission does not describe an AI/ML powered device and therefore, the information requested about acceptance criteria and studies proving the device meets the criteria in the context of AI/ML is not available in the provided text.

The document discusses performance data related to the physical characteristics of the molds and the resulting spacers, but not in the context of an AI/ML algorithm's performance. Therefore, I cannot provide information on:

• A table of acceptance criteria and reported device performance for an AI/ML device.
• Sample size and data provenance for an AI/ML test set.
• Number and qualifications of experts for AI/ML ground truth.
• Adjudication method for an AI/ML test set.
• Multi-reader multi-case (MRMC) comparative effectiveness study for AI assistance.
• Standalone AI algorithm performance.
• Type of ground truth used for AI/ML.
• Sample size and ground truth establishment for an AI/ML training set.

The performance data mentioned in the document relates to:

• Sterilization and Shelf Life: Validation according to ISO 11135, shelf life of 2 years.
• Biocompatibility: Categorized per ISO 10993-1, with tests performed including Cytotoxicity (ISO 10993-5), Sensitization (ISO 10993-10), Intracutaneous reactivity (ISO 10993-23), Pyrogenicity (ISO 10993-11), and Acute systemic toxicity (ISO 10993-11).
• Mechanical Performance Testing:
  • Endurance properties of stemmed femoral hip components according to ISO 7206-4 and ISO 7206-6.
  • Wear of total knee-joint prosthesis according to ISO 14243-1.
  • Endurance properties of tibial trays according to ASTM F1800.
  • Endurance properties of shoulder spacer stem and neck region based on ISO 7206-4 and ISO 7206-6.
  • Antibiotic (gentamicin) elution testing.

These tests are designed to demonstrate the physical and biological safety and effectiveness of the medical device molds and the spacers they produce, showing substantial equivalence to predicate devices, rather than evaluating the performance of an AI/ML algorithm.

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BonOs® Inject bone cement is indicated for the treatment of pathological fractures of the vertebral body due to osteoporosis, cancer, or benign lesions using vertebroplasty or balloon kyphoplasty procedure.

When used in conjunction with NEO Pedicle Screw System™ BonOs® Inject is intended to restore the integrity of the spinal column even in the absence of fusion for a limited time in patients with advanced stage tumors involving the thoracic and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion. NEO Pedicle Screws augmented with BonOs® Inject Cement are for use at spinal levels where the structural integrity of the spine is not severely compromised.

The NEO Pedicle Screw System™, when used as a posterior pedicle screw system, is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion. The system is intended for posterior, non-cervical fixation for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, tumor, pseudarthrosis, and/or failed previous fusion.

When used in conjunction with BonOs® Inject Cement, the NEO Pedicle Screw System™ is intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the thoracic and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion. NEO Pedicle Screws augmented with BonOs® Inject Cement are for use at spinal levels where the structural integrity of the spine is not severely compromised.

BonOs® Inject:
BonOs® Inject is a radiopaque, injectable bone cement for use in spine surgery like percutaneous vertebral augmentation during vertebroplasty or kyphoplasty. It is a two-component system consisting of a powder and a liguid. Methylmethacrylate polymer is the primary constituent of the powder component. Zirconium dioxide is added as radiopacifier. Methylmethacrylate monomer is the primary constituent of the liquid component. Mixing the two separate sterile components, initially an injectable paste is produced which can be transferred into a syringe and which then can be injected under slight pressure into the vertebral body. After curing of the bone cement by exothermic polymerization it stabilizes the vertebral lesions and vertebral compression fractures.

Neo Pedicle Screw System™:
The Neo Pedicle Screw System™ consists of pedicle screws and connecting rods which differ in length and diameter. The system includes the relevant instruments which are single use, disposable and delivered sterile. All components and instruments are sterilized by gamma irradiation.

The screws are offered in diameters of 5.0 - 7.0 mm and lengths of 35 - 55mm. Three different types of rods are available: pre-bent, straight or special bent rod for S1/L5. All rods have a diameter of 5.5 mm. Pre-bent rods are offered in lengths of 40 - 100mm, straight rods in lengths from 30 - 300 mm and the special-bent rod in either 30 or 40mm length. All spinal implant components are made of titanium alloy (Ti6Al4V Eli) in accordance with ASTM F136. The screws are color coded for better identification of the different diameters. The screws are double threaded, cannulated, fenestrated and selftapping.

Since it states that there were no changes made to the existing devices BonOs® Inject (K090460) and Neo Pedicle Screw System™ (K171582) and no additional testing was required or performed for these specific devices, I am unable to extract all the requested information for acceptance criteria and study details. However, I can provide the available information regarding the additional predicate device comparison.

Here's a summary of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the sample sizes for the axial pullout strength, cement flow, or bolus formation tests. The data provenance is not specified (e.g., country of origin, retrospective or prospective).

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Not applicable. The tests mentioned are mechanical and biological performance tests, not those requiring expert consensus on clinical ground truth.

4. Adjudication Method for the Test Set

Not applicable. The tests mentioned are objective performance tests.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done.

6. Standalone (Algorithm Only) Performance

Not applicable, as this is a physical medical device (bone cement and screw system), not a software algorithm.

7. Type of Ground Truth Used

For the axial pullout strength and cement flow/bolus formation, the "ground truth" was established by comparison to the performance of the predicate device (Kyphon™ Xpede™ Bone Cement Medtronic HV-R™ Fenestrated Screw Cement CD Horizon™ Fenestrated Screw Set) as per established ASTM standards.
For bacterial endotoxins and pyrogen limits, established regulatory standards (Ph. Eur., USP, FDA guidance) served as the ground truth.

8. Sample Size for the Training Set

Not applicable. This document describes the substantial equivalence of a physical medical device, not a machine learning algorithm that requires a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set mentioned.

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BonOs® HV Genta, BonOs® MV Genta and BonOs® LV Genta are intended for the fixation of prothesis to living bone in the second stage of a two-stage revision for total joint arthroplasty after the initial infection has been cleared.

BonOs® HV Genta, BonOs® MV Genta and BonOs® LV Genta are PMMA, radiopaque bone cements, containing gentamicin, designed for the fixation of prothesis to the living bone. BonOs® HV Genta, BonOs® MV Genta and BonOs® LV Genta are traditional bone cement products. The bone cement is made of two separate sterile components. When both components are mixed together, they become a self-hardening, radiopaque bone cement which fixes the implant and transfer stresses evenly to the bone. The liquid is contained in a vial and the powder in a pouch; these components are packed in blister with Tyvek lid or an aluminium pouch. The devices are sold disposable, singleuse and sterile.

This document is a 510(k) summary for the BonOs® HV Genta, BonOs® MV Genta, and BonOs® LV Genta bone cements. It does not describe a study involving an AI/ML powered device, but rather a traditional medical device (bone cement). Therefore, many of the requested fields are not applicable in this context.

Here's the information that can be extracted or noted as not applicable:

1. A table of acceptance criteria and the reported device performance

The document states that performance testing was conducted in accordance with the "FDA Class II Special Controls Guidance Document: Polymethylmethacrylate (PMMA) Bone Cement; Guidance for Industry and FDA" dated July 17, 2002. It also notes compliance with several ASTM and ISO standards for mechanical and physical properties.

Specific acceptance criteria and reported numerical performance values are not provided in this summary. Instead, the summary generally states that "Results show comparable performances to the predicate device and are in compliance with ASTM F451-16, ISO 5833:2002, ISO 527:1/2, ASTM F2118-14, ASTM D2990-17, ASTM D732-17 and ASTM E399-20."

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the 510(k) summary. The document describes a traditional device and its performance testing against standards, not a clinical study with a "test set" in the context of an AI/ML device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This is not applicable as this is not an AI/ML device requiring human expert ground truth for its performance evaluation in that sense. The device's performance is established through laboratory testing against established physical, chemical, and mechanical standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This is not applicable as this is not an AI/ML device and does not involve human readers adjudicating findings.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This is not applicable as this is not an AI/ML device.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

This is not applicable as this is not an AI/ML device.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

For this traditional medical device, the "ground truth" for performance is based on:

• Compliance with recognized international and national standards (ISO, ASTM).
• Laboratory test results for physical, chemical, mechanical, and biological properties, compared against pre-defined specifications and/or predicate device performance.

8. The sample size for the training set

This is not applicable as this is not an AI/ML device and therefore does not have a "training set."

9. How the ground truth for the training set was established

This is not applicable as this is not an AI/ML device and therefore does not have a "training set" or corresponding ground truth.

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BonOs® HV, BonOs® MV and BonOs® LV are intended to be used for the fixation of artificial joint protheses to the host bone.

BonOs® HV, BonOs® MV and BonOs® LV are PMMA, radiopaque bone cements, designed for the fixation of prothesis to the living bone. BonOs® HV, BonOs® MV and BonOs® LV are traditional bone cement products. The bone cement is made of two separate sterile components. When both components are mixed together, they become a self-hardening, radiopaque bone cement which fixes the implant and transfer stresses evenly to the bone. The liguid is contained in a vial and the powder in a pouch: these components are packed in blister with Tyvek lid or an aluminium pouch. The devices are sold disposable, single-use and sterile.

The provided text is a 510(k) Summary for a medical device called BonOs® HV, BonOs® MV, and BonOs® LV, which are PMMA bone cements. This document outlines the general information about the device, its classification, comparison to predicate devices, and performance data.

However, it does not contain information related to a study proving the device meets acceptance criteria concerning AI/ML performance, human readers, or ground truth establishment based on expert consensus/adjudication typical for AI/ML device clearances.

The performance data summarized in this document pertains to traditional medical device testing for bone cements, such as:

• Sterilization and Shelf Life: Validated according to ISO 11135 and ISO 13408-1/2.
• Biocompatibility: Performed according to ISO 10993-1, with identical materials to other bone cements on the market.
• Performance Testing (Chemical, Material, and Mechanical): Included mixing and application characteristics, chemical composition, molecular weight and polymer structure, physical properties, stability of components, thermal properties, and mechanical properties. These tests were conducted in accordance with "FDA Class II Special Controls Guidance Document: Polymethylmethacrylate (PMMA) Bone Cement; Guidance for Industry and FDA" dated July 17, 2002, and met standards like ASTM F451-16, ISO 5833:2002, etc.
• Bacterial Endotoxins: Evaluated using Recombinant Factor C Assay (EndoZyme) following Ph. Eur. 5.01.10, based on USP , meeting endotoxin limits.

Therefore, I cannot populate the requested table and answer the specific questions about AI/ML device performance, human readers, sample sizes for AI/ML test/training sets, or expert-based ground truth establishment. The document describes a traditional substantial equivalence determination for a physical medical device (bone cement), not an AI/ML powered device.

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Hi-Fatigue Bone Cement is intended for use in arthroplastic procedures of the hip, knee and other joints for the fixation of polymer or metallic prosthetic implants to living bone.

Hi-Fatique Bone Cement is a PMMA, radiopaque bone cement, designed for the fixation of prothesis to the living bone. Hi-Fatigue Bone Cement is a traditional bone cement product. The bone cement is made of two separate sterile components. When both components are mixed together, they become a self-hardening, radiopaque bone cement which fixes the implant. The liquid is contained in a vial and the powder in a pouch; these components are packed in blister with Tyvek lid or an aluminium pouch. The devices are sold disposable, single-use and sterile.

This appears to be a 510(k) summary for a bone cement device, not an AI/ML medical device. Therefore, the requested information about acceptance criteria, study details, and ground truth establishment for AI/ML performance is not found in this document.

The document discusses performance data related to the physical and chemical properties of bone cement, referring to a "FDA Class II Special Controls Guidance Document: Polymethylacrylate (PMMA) Bone Cement; Guidance for Industry and FDA" dated July 17, 2002.

Here's an attempt to extract relevant information, acknowledging the mismatch with the prompt's AI/ML focus:

1. A table of acceptance criteria and the reported device performance

The document states that "The performance data demonstrate that the new devices Hi-Fatigue Bone Cement is substantially equivalent to the predicate device Palacos® R... and meet the requirements of the Special Controls Guidance document."

Unfortunately, the specific acceptance criteria values (e.g., minimum compressive strength, maximum polymerization temperature) and the reported device performance values for each of the mechanical, physical, and chemical properties are not explicitly listed in a comparative table within this 510(k) summary. The summary only lists the types of tests performed.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the 510(k) summary. The performance data section vaguely states "non-clinical performance testing was performed."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This is not applicable as the device is a bone cement, not an AI/ML imaging device requiring expert ground truth for interpretation.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This is not applicable as the device is a bone cement.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This is not applicable as the device is a bone cement, not an AI/ML imaging device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This is not applicable as the device is a bone cement.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For a bone cement, "ground truth" would relate to the established physical, chemical, and biological properties defined by industry standards or regulatory guidance. The document states that testing was "in accordance with the 'FDA Class II Special Controls Guidance Document: Polymethylacrylate (PMMA) Bone Cement; Guidance for Industry and FDA' dated July 17, 2002." This guidance document would define the expected performance characteristics that the device must meet or be substantially equivalent to.

8. The sample size for the training set

This is not applicable as the device is a bone cement and does not involve AI/ML training.

9. How the ground truth for the training set was established

This is not applicable as the device is a bone cement and does not involve AI/ML training.

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Hi-Fatigue G Bone Cement is intended for use in arthroplastic procedures of the hip, knee and other joints for the fixation of polymer or metallic prosthetic implants to living bone when reconstruction is necessary. The cement is intended for use in the second stage of a two-stage revision for total joint arthroplasty after the initial infection has been cleared.

Hi-Fatique G Bone Cement is a PMMA, radiopaque bone cement, containing gentamicin, designed for the fixation of prothesis to the living bone. Hi-Fatigue G Bone Cement is a traditional bone cement product. The bone cement is made of two separate sterile components. When both components are mixed together, they become a selfhardening, radiopaque bone cement which fixes the implant. The liquid is contained in a vial and the powder in a pouch; these components are packed in blister with Tyvek lid or an aluminium pouch. The devices are sold disposable, single-use and sterile.

The provided text describes the 510(k) submission for Hi-Fatigue G Bone Cement and focuses on the non-clinical performance data to establish substantial equivalence to predicate devices, rather than a study involving AI or human readers. Therefore, I cannot provide information on acceptance criteria and a study proving the device meets them in the context of AI performance, MRMC studies, or human reader improvement with AI.

However, I can extract the acceptance criteria and study information related to the device's physical, chemical, and mechanical properties based on the "FDA Class II Special Controls Guidance Document: Polymethylacrylate (PMMA) Bone Cement; Guidance for Industry and FDA" dated July 17, 2002.

Acceptance Criteria and Reported Device Performance

The document states that "The performance data fulfill the pre-defined acceptance criteria and demonstrate that the new devices Hi-Fatigue G Bone Cement is substantially equivalent to the predicate device Palacos® R+G... and meet the requirements of the Special Controls Guidance document."

The text lists categories of performance testing but does not provide specific numerical acceptance criteria or the exact reported device performance values for each. It broadly states that the device meets the criteria.

Details Regarding the Study

• Sample size used for the test set and the data provenance: Not specified. The document refers to "performance data" and "non-clinical performance testing" without detailing sample sizes for each test. The data provenance is not explicitly stated.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The "ground truth" here refers to established engineering and material science standards (e.g., precise measurements of mechanical properties, chemical composition analysis) rather than expert interpretation of medical images or patient data.
• Adjudication method for the test set: Not applicable. The tests are objective measurements against defined standards.
• If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This document pertains to a bone cement device, not an AI-powered diagnostic or assistive tool for human readers.
• If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is not an algorithm or AI device.
• The type of ground truth used: The ground truth is based on established engineering standards for material properties, chemical composition, and performance characteristics of bone cement, as outlined in the "FDA Class II Special Controls Guidance Document: Polymethylacrylate (PMMA) Bone Cement; Guidance for Industry and FDA" and relevant USP/Ph. Eur. standards for endotoxins.
• The sample size for the training set: Not applicable. This is not an AI/machine learning device that requires a training set.
• How the ground truth for the training set was established: Not applicable.

In summary, the provided text describes the non-clinical testing of a bone cement device against established material science and medical device standards, not against AI performance metrics or human perception studies.

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